Overweight and Obesity Clinical Trial
Official title:
Lipogenesis, Lipoprotein Flux, and CVD Risk: Role of Meal Composition and Frequency
Verified date | May 2022 |
Source | University of California, San Francisco |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to find out how the amount of fat or sugar in a person's diet, or the number of meals eaten each day, affect the amount of fat that people's bodies make, the types of fats in the bloodstream, and how much fat is stored in the liver. The study is funded by the National Institutes of Health.
Status | Active, not recruiting |
Enrollment | 48 |
Est. completion date | December 2022 |
Est. primary completion date | December 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years to 65 Years |
Eligibility | Inclusion Criteria: - overweight or obese men and women - ages 20-65 years Exclusion Criteria: - pregnancy or lactation within the past six months - type 1 or 2 diabetes mellitus] - AST and ALT above upper limit of normal (ULN) - fasting triglyceride or total cholesterol levels >ULN - Hgb below the lower of limit of normal - positive HIV antibody test or hepatitis serologies - use of any antidiabetic medications or lipid-lowering drugs - history of surgery for obesity - change in body weight >5% within preceding 6 months (self report) - claustrophobia, presence of metal implants - weight over 350 lbs |
Country | Name | City | State |
---|---|---|---|
United States | University of California, San Franciso, San Francisco General Hospital | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco | Touro University, California |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Liver fat content | Effects of diet composition or meal frequency on fat stored in the liver.
Liver fat content will be measured non-invasively using magnetic resonance spectroscopy. |
After 10-day dietary period | |
Other | Lipids and lipoproteins in the blood | Effects of diet composition or meal frequency on the types of fats in the bloodstream that might affect risk of heart disease.
The types of fats in the bloodstream will be measured in blood samples collected while the participant is fasting and also during the stable isotope/feeding study of de novo lipogenesis. |
After 10-day dietary intervention period | |
Primary | Effect of meal composition on fractional de novo lipogenesis (fatty acid synthesis) | Differences between high carbohydrate and high fat diets on postprandial de novo lipogenesis
De novo lipogenesis will be measured using stable (not radioactive) isotopes given intravenously and orally during feeding. |
After 10-day dietary period | |
Secondary | Effect of meal frequency on fractional de novo lipogenesis (fatty acid synthesis) | Differences between consuming the same diet as eight small meals per day or two larger meals per day on postprandial de novo lipogenesis.
Please see description of measurement of de novo lipogenesis under aim 1. |
After 10-day dietary period |
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